Guiding Breast Cancer Treatment | Oncotype DX Test

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Node-Negative

The Oncotype DX Breast Recurrence Score test is the only test validated to predict chemotherapy benefit for your patients with HR+, HER2-, node-negative, early-stage, invasive breast cancer and help to guide treatment decisions.^1-4

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Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - TAILORx and NSABP B-20 results show that most patients do not benefit from chemotherapy.

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Clinical evidence has demonstrated:

Patients with Recurrence Score^® results 0–25 do not benefit from the addition of chemotherapy to endocrine therapy1-4
Patients with Recurrence Score results 26–100 derive a 26% absolute benefit (group average) from the addition of chemotherapy to endocrine therapy3
An exploratory analysis suggests that patients ≤50 years of age with Recurrence Score results 16–25 may benefit from chemotherapy2,4

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In TAILORx, an exploratory analysis suggests that the effect of chemotherapy significantly differs across age groups and Recurrence Score results for invasive disease-free survival* and distant recurrence-free interval**.

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Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients -TAILORx analysis - Guiding Treatment based on Recurrence Score Results and Age.

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* Invasive disease–free survival defined as the first event of distant recurrence, local–regional recurrence, contralateral breast or other second primary cancer, or death without cancer recurrence.
** Distant recurrence-free internal defined as first event of distant recurrence or death from breast cancer.

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Clinical risk features alone (tumour size, grade, clinical risk category) are proven to be prognostic-only and insufficient to determine chemotherapy benefit²

Exploratory analyses were performed to evaluate whether subgroups may derive benefit from the addition of chemotherapy to endocrine therapy in patients with Recurrence Score results 11–25²

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Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - Exploratory analyses - No benefit from the addition of chemotherapy to endocrine therapy in patients with Recurrence Score results 11–25.

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High clinical risk patients

73% of patients with high clinical risk had Recurrence Score results 0-25 and may have been overtreated if decisions had been made without the Oncotype DX test

Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - can help reduce risks of over- and undertreatment in high and low clinical risk patients.

Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - can help reduce risks of over- and undertreatment in high and low clinical risk patients.

Low clinical risk patients

43% of patients with Recurrence Score results 26-100 had low clinical risk and may have been undertreated if decisions had been made without the Oncotype DX test

Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - can help reduce risks of over- and undertreatment in high and low clinical risk patients.

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a Low clinical risk defined by low grade and tumour size ≤3 cm, intermediate grade and tumour size ≤2 cm, and high grade and tumour size ≤1 cm; high clinical risk defined as all other cases with known values for grade and tumour size

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The Oncotype DX Breast Recurrence Score test is the standard of care to guide adjuvant treatment in HR+, HER2–, early-stage breast cancer, for both node-negative and node-positive patients^5-10

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Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - standard of care to guide adjuvant treatment in HR+, HER2–, early-stage breast cancer patients.

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Since clinical risk features alone are not sufficient to determine CT benefit, the Oncotype DX Breast Recurrence Score test should be used for^2,16:

All patients for whom chemotherapy may be spared

All patients for whom chemotherapy may be life-saving

References

Paik et al. J Clin Oncol. 2006.
Andre et al. J Clin Oncol. 2022.
Geyer et al. NPJ Breast Cancer. 2018.
Sparano et al. SABCS 2022, Abstract GS1-05.
Barni et al. ESMO. 2018.
Gligorov et al. Oncologist. 2015.
Curtit et al. Breast. 2019.
Barni et al EBCC. 2018.
Battisti et al. EBCC. 2019.
Petráková et al. St Gallen conference. 2019.
Sparano and Paik. J Clin Oncol. 2008.
Sparano et al. N Engl J Med. 2015.
Blok et al. Cancer Treatment Reviews. 2018.
Albanell et al. Eur J Cancer. 2016.
Hochheiser. J Comp Eff Res. 2019.
Bello et al. Ann Surg Oncc. 2018.
Sparano et al. N Engl J Med. 2019.
NCCN Guidelines Insights: Breast Cancer, version 4.2022. https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
IQWIG Press Release, September 2018
NICE Diagnostics Guidance DG34 December 2018. https://www.nice.org.uk/guidance/dg34 accessed December 2018.
Burstein et al. Ann Oncol. 2021.
Andre et al. J Clin Oncol. 2022.
Cardoso et al. Ann Oncol. 2019.

National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. ASCO and ESMO are trademarks of the American Society of Clinical Oncology and European Society for Medical Oncology.
NCCN, National Institute for Health and Care Excellence (NICE), St Gallen International Consensus Panel, ASCO and ESMO do not endorse any product or therapy.
NICE DG34 2018 Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. Available from HYPERLINK "http://www.nice.org.uk/guidance/dg34"www.nice.org.uk/guidance/dg34. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication

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Node-Positive

The Oncotype DX Breast Recurrence Score test is predictive of chemotherapy benefit for your postmenopausal patients with HR+, HER2-, node-positive (1-3 positive nodes), early-stage, invasive breast cancer as demonstrated by SWOG-88141. Data from SWOG-8814 and RxPONDER show that a substantial proportion of these patients may be spared chemotherapy.^1-3

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Oncotype DX value in clinical practice for node-positive, early-stage breast cancer patients - standard of care to guide adjuvant treatment in HR+, HER2–, early-stage breast cancer patients.

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SWOG 8814 study established the Oncotype DX^® test as predictive of CT benefit in node-positive postmenopausal patients1. Initial results from the RxPONDER study add to the findings of SWOG 8814 by providing a refined estimate of CT benefit in N1 patients with the following results^2,3:

N1 postmenopausal patients with Recurrence Score^® results 0-25 may be spared chemotherapy, independent of clinical pathological parameters^2,3.
N1 premenopausal patients with Recurrence Score results 0-25 derive a 2.4% benefit from chemotherapy in terms of distant recurrence-free interval at 5 years³.

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A large proportion^4,5 of HR+, HER2-, node-positive postmenopausal patients receive chemotherapy as node-positive disease is considered high clinical risk due to worse prognosis⁶. Average chemotherapy treatment rates without genomic testing are in the range of 70% for this patient population^4,5. RxPONDER demonstrated that many of these patients may be overtreated, assuming that chemotherapy was considered because of their high clinical risk^2,3, and the Oncotype DX test can help make informed treatment decisions.

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Another recent study published in 2023 shows that the Oncotype DX test increases confidence and concordance among oncologists in adjuvant chemotherapy recommendations for early-stage breast cancer⁸

The study concludes that

the Oncotype DX^® test significantly reduces uncertainty related to therapeutic decisions

the Oncotype DX^® test reduces discordance in treatment choice among oncologists

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In summary, adjuvant chemotherapy may be guided with the Oncotype DX test to identify a significant proportion of node-positive patients (with up to 3 positive nodes) who may not benefit from the addition of chemotherapy^1-3.

The Oncotype DX Breast Recurrence Score* test should be used for:

All patients for whom chemotherapy may be spared^1-3

All patients for whom chemotherapy may be life-saving^1-3

*For early stage, HR+, HER2- patients with up to 3 nodes involved

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References

Albain et al. Lancet Oncol. 2010.
Kalinsky et al. NEJM. 2021.
Kalinsky et al. SABCS. 2021.
Allemani et al. Int J Cancer. 2013.
Zhang et al. Breast Can Res Treat. 2020.
Tonellotto et al. Eur J Breast Health. 2019.
Bello et al. Ann Surg One. 2018.
Licata L, et al. NPJ Breast Cancer. 2023.

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Have questions about Oncotype DX^®?

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Value in clinical practice

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References

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References

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References

References